Bioequivalence and Bioavailability Forum

Hi Regaffairs,

now I - hopefully - got your point

❝ We have claimed BCS waiver based on the applicable guideline and also have submitted the invitro dissolution data performed in the required regulatory media. The disso profile met the applicable requirement with more than 85% release in desired 30 minutes and F2 values > 50.

❝

❝ The application was reversed citing information on biostudy.

Remember that guidelines are guidelines, not laws...
You may apply for a biowaiver, but there is no guarantee that it will be granted.
Did the regulator give any explanations for the rejection?

If you decide to go for a biostudy, I would suggest do perform it with new batches of both test and reference, because:

❝ Is there any time regulatory time frame where in the time lag between the formulation manufactured and the BE conducted is freezed / discussed ?

IMHO no, but...

❝ If not, how could I support the BE using the old samples to the regulatory body ?

You mentioned in your original post, that after 24 months your product is still within the shelf life specifications (95% or 90% or ...?).
Assuming that you don't have enough samples of the reference product you used in the in vitro study left to perform a biostudy, you will have to use a new batch of the reference anyhow.
By this you will have to increase your sample size, since you should expect a lower point estimate in the comparison Test_old vs. Ref_new.
I am not sure, whether the regulator will accept this study - even if you are not discouraged from such a case in a guideline...

Regards,
Hermann